Trade Name: Methocarbamol

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Somerset Therapeutics, LLC

Presentation: INJECTION, HUMAN PRESCRIPTION DRUG

Strength: 100 mg/mL

Storage and handling

METHOCARBAMOL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • Methocarbamol injection, USP Injectable, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration.
  • Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q. s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.u00a0 The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula of CHNOIts molecular weight is 241.24. The structural formula is shown below.
  • Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and -hexane.
  • Methocarbamol Injectable has a pH between 3.5 and 6.0.
  • AFTER MIXING WITH I.V. INFUSION FLUIDS, n
  • The mechanism of action of methocarbamol in humans has not been established, but may be due to general CNS depression.u00a0 It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.
  • In healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and 0.80 L/h/kg, the mean plasma elimination half-life ranges between 1 and 2 hours, and the plasma protein binding ranges between 46% and 50%.
  • Methocarbamol is metabolized via dealkylation and hydroxylation. Conjugation of methocarbamol also is likely. Essentially all methocarbamol metabolites are eliminated in the urine. Small amounts of unchanged methocarbamol also are excreted in the urine.
  • SPECIAL POPULATIONS
  • Elderly
  • The mean (u00b1SD) elimination half-life of methocarbamol in elderly healthy volunteers (mean (u00b1SD) age, 69 (u00b14) years) was slightly prolonged compared to a younger (mean (u00b1SD) age, 53.3 (u00b18.8) years), healthy population (1.5 (u00b10.4) hours versus 1.1 (u00b10.27) hour, respectively). The fraction of bound methocarbamol was slightly decreased in the elderly versus younger volunteers (41 to 43% versus 46 to 50%, respectively).u00a0
  • Renally impaired
  • The clearance of methocarbamol in 8 renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (u00b1SD) elimination half-life in these two groups was similar (1.2 (u00b10.6) versus 1.1 (u00b1 0.3) hours, respectively).
  • Hepatically impaired
  • In 8 patients with cirrhosis secondary to alcohol abuse, the mean total clearance of methocarbamol was reduced approximately 70% compared to that obtained in 8 age- and weight-matched normal subjects. The mean (u00b1SD) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (u00b11.62) hours and 1.11 (u00b10.27) hours respectively. The percent of methocarbamol bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in the normal subjects.
  • The injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
  • Methocarbamol Injectable should not be administered to patients with known or suspected renal pathology. This caution is necessary because of the presence of polyethylene glycol 300 in the vehicle.
  • A much larger amount of polyethylene glycol 300 than is present in recommended doses of Methocarbamol Injectable is known to have increased pre-existing acidosis and urea retention in patients with renal impairment. Although the amount present in this preparation is well within the limits of safety, caution dictates this contraindication.
  • Methocarbamol Injectable is contraindicated in patients hypersensitive to methocarbamol or to any of the injection components.
  • Since methocarbamol may posses a general CNS depressant effect, patients receiving Methocarbamol Injectable should be cautioned about combined effects with alcohol and other CNS depressants.
  • Safe use of Methocarbamol Injectable has not been established with regard to possible adverse effects upon fetal development. There have been very rare reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Methocarbamol Injectable should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see ).
  • Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.
  • No data
  • The following adverse reactions have been reported coincident with the administration of methocarbamol. Some events may have been due to an overly rapid rate of intravenous injection.
  • Body as a whole
  • Cardiovascular system
  • In most cases of syncope there was spontaneous recovery. In others, epinephrine, injectable steroids, and/or injectable antihistamines were employed to hasten recovery.
  • Digestive system
  • Hemic and lymphatic system
  • Immune system:
  • Nervous system
  • The onset of convulsive seizures during intravenous administration of methocarbamol has been reported in patients with seizure disorders. The psychic trauma of the procedure may have been a contributing factor. Although several observers have reported success in terminating epileptiform seizures with Methocarbamol Injectable, its administration to patients with epilepsy is not recommended (see , ).
  • Skin and special senses
  • Other
  • Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma. In post-marketing experience deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.
  • Treatment
  • Management of overdose includes symptomatic and supportive treatment. Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. The usefulness of hemodialysis in managing overdose is unknown.
  • For Intravenous and Intramuscular Use Only
  • For the relief of symptoms of moderate degree, one dose of 1 gram (one 10 mL vial) may be adequate. Ordinarily this injection need not be repeated, as the administration of the oral form will usually sustain the relief initiated by the injection. For the severest cases or in postoperative conditions in which oral administration is not feasible, additional doses of 1 gram may be repeated every 8 hours up to a maximum of 3 g/day for no more than 3 consecutive days.
  • Methocarbamol Injection USP, 1,000 mg/10 mL (100 mg/mL) is a clear, colorless solution.
  • Total Drug Content: Methocarbamol USP 1,000 mg in 10 mL.
  • 10 mL vials are single dose vials packaged as;
  • - 5 vials per tray,
  • - 10 vials per tray and
  • - 25 vials per tray.
  • Store at 20n- u00b0- 25u00b0C (68u00b0F - 77u00b0F), excursions permitted to 15u00b0 - 30u00b0C (59u00b0F - 86u00b0F). [see USP Controlled Room Temperature].
  • Discard unused portion.
  • To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or FDA at 1-800 FDA-1088 or www.fda.gov/medwatch
  • u00a0
  • Manufactured by:u00a0
  • Wintac Limited
  • Bangalore 562 123
  • India.
  • Code No.: KR/DRUGS/KTK/28/289/97
  • Manufactured for:
  • Somerset Therapeutics, LLC
  • Somerset, NJ 08873
  • ST-MET11/P/02
  • Revised: June 2018
  • Container label u2013 10 mL
  • Carton label - Pack of 5 Vials
  • Carton label - Pack of 10 Vials
  • Carton label - Pack of 25 Vials

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Methocarbamol (Methocarbamol) which is also known as Methocarbamol and Manufactured by Somerset Therapeutics, LLC. It is available in strength of 100 mg/mL.

Methocarbamol (Methocarbamol) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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